Prospective Longitudinal Observational Cohort Study Research Articles

Prospective Exploration of Cognitive-Communication Changes With Woodcock-Johnson IV Before and After Sport-Related Concussion.

Purpose The purpose of this study was to evaluate changes in cognitive-communication performance using Woodcock-Johnson IV Tests (WJIV) from pre-injury baseline to post sport-related concussion. It was hypothesized that individual subtest performances would decrease postinjury in symptomatic individuals. Method This prospective longitudinal observational nested cohort study of collegiate athletes assessed cognitive-communicative performance at preseason baseline and postinjury. Three hundred and forty-two male and female undergraduates at high risk for sport-related concussion participated in preseason assessments, and 18 individuals met criteria post injury. WJIV subtest domains included Word Finding, Speeded Reading Comprehension, Auditory Comprehension, Verbal Working Memory, Story Retell, and Visual Processing (letter and number). The power calculation was not met, and therefore data were conservatively analyzed with descriptive statistics and a planned subgroup analysis based on symptomatology. Results Individual changes from baseline to postinjury were evaluated using differences in standard score performance. For symptomatic individuals, mean negative decreases in performance were found for Retrieval Fluency, Sentence Reading Fluency, Pattern Matchings, and all cluster scores postinjury. Individual performance declines also included decreases in story retell, verbal working memory, and visual processing. Conclusions This study identified within-subject WJIV performance decline in communication domains post sport-related concussion and reinforces that cognitive-communication dysfunction should be considered in mild traumatic brain injury. Key cognitive-communication areas included speeded naming, reading, and verbal memory, though oral comprehension was not sensitive to change. Future clinical research across diverse populations is needed to expand these preliminary findings.

Prediction of Persistent Pain Severity and Impact 12 Months After Breast Surgery Using Comprehensive Preoperative Assessment of Biopsychosocial Pain Modulators.

Persistent post-mastectomy pain (PPMP) is a significant negative outcome occurring after breast surgery, and understanding which individual women are most at risk is essential to targeting of preventive efforts. The biopsychosocial model of pain suggests that factors from many domains may importantly modulate pain processing and predict the progression to pain persistence. This prospective longitudinal observational cohort study used detailed and comprehensive psychosocial and psychophysical assessment to characterize individual pain-processing phenotypes in 259 women preoperatively. Pain severity and functional impact then were longitudinally assessed using both validated surgery-specific and general pain questionnaires to survey patients who underwent lumpectomy, mastectomy, or mastectomy with reconstruction in the first postsurgical year. An agnostic, multivariable modeling strategy identified consistent predictors of several pain outcomes at 12months. The preoperative characteristics most consistently associated with PPMP outcomes were preexisting surgical area pain, less education, increased somatization, and baseline sleep disturbance, with axillary dissection emerging as the only consistent surgical variable to predict worse pain. Greater pain catastrophizing, negative affect, younger age, higher body mass index (BMI), and chemotherapy also were independently predictive of pain impact, but not severity. Sensory disturbance in the surgical area was predicted by a slightly different subset of factors, including higher preoperative temporal summation of pain. This comprehensive approach assessing consistent predictors of pain severity, functional impact, and sensory disturbance may inform personalized prevention of PPMP and also may allow stratification and enrichment in future preventive studies of women at higher risk of this outcome, including pharmacologic and behavioral interventions and regional anesthesia.

Prospective cohort study of patients with advanced cancer and their relatives on the experienced quality of care and life (eQuiPe study): a study protocol

BackgroundPalliative care is becoming increasingly important because the number of patients with an incurable disease is growing and their survival is improving. Previous research tells us that early palliative care has the potential to improve quality of life (QoL) in patients with advanced cancer and their relatives. According to limited research on palliative care in the Netherlands, patients with advanced cancer and their relatives find current palliative care suboptimal. The aim of the eQuiPe study is to understand the experienced quality of care (QoC) and QoL of patients with advanced cancer and their relatives to further improve palliative care.MethodsA prospective longitudinal observational cohort study is conducted among patients with advanced cancer and their relatives. Patients and relatives receive a questionnaire every 3 months regarding experienced QoC and QoL during the palliative trajectory. Bereaved relatives receive a final questionnaire 3 to 6 months after the patients’ death. Data from questionnaires are linked with detailed clinical data from the Netherlands Cancer Registry (NCR). By means of descriptive statistics we will examine the experienced QoC and QoL in our study population. Differences between subgroups and changes over time will be assessed while adjusting for confounding factors.DiscussionThis study will be the first to prospectively and longitudinally explore experienced QoC and QoL in patients with advanced cancer and their relatives simultaneously. This study will provide us with population-based information in patients with advanced cancer and their relatives including changes over time. Results from the study will inform us on how to further improve palliative care.Trial registrationTrial NL6408 (NTR6584). Registered in Netherlands Trial Register on June 30, 2017.

Assessment of the Progression of Vertical Semicircular Canal Dysfunction and Increased Vestibular Endolymphatic Hydrops in Patients With Early-Stage Ménière Disease

Vertical semicircular canals and endolymphatic hydrops play important roles in the pathophysiological mechanisms of Ménière disease. However, their characteristics and associations with disease progression during medical treatment have not been determined. To examine the function of both the horizontal and vertical semicircular canals in patients with Ménière disease and to evaluate the change in endolymphatic hydrops volume during medical treatment, including treatment with diuretic therapy, over a 2-year period. This prospective longitudinal observational cohort study included 55 patients with definite unilateral Ménière disease and was performed in a tertiary care hospital in Japan. Participants were enrolled between April 1, 2017, and January 31, 2018, and those with vestibular migraine were excluded. All participants received education regarding diet and lifestyle modifications and treatment with betahistine mesylate (36 mg daily) and/or an osmotic diuretic (42-63 mg daily). Patients were followed up for vertigo and hearing evaluations at least once per month for more than 12 months and were instructed to record episodes of vertigo in a self-check diary. Audiometry was performed monthly, video head impulse testing and caloric testing were performed every 4 months, and magnetic resonance imaging was conducted annually. Data were analyzed from May 15, 2017, to January 31, 2020. Neurootological testing to evaluate vestibuloocular reflex gain over time, magnetic resonance imaging to evaluate the change in endolymphatic hydrops volume over time, and monthly vertigo and hearing evaluations for more than 12 months. Among 55 participants with definite Ménière disease, 32 patients (58.2%) were female, and the mean (SD) age was 59.0 (15.1) years. The median disease duration was 2 years (interquartile range, 0-4 years), with 43 patients (78.2%) having an early stage (ie, disease duration ≤4 years) of Ménière disease. Over the 2-year study period, the vestibuloocular reflex gain decreased from 0.76 to 0.56 in the superior semicircular canals, for a difference of 0.20 (95% CI, 0.14-0.26) and from 0.68 to 0.50 in the posterior semicircular canals, for a difference of 0.18 (95% CI, 0.14-0.22). The maximum slow-phase velocity and vestibuloocular reflex gain in the horizontal semicircular canals were maintained. The volume ratio of vestibular endolymphatic hydrops increased from 19.7% to 23.3%, for a difference of 3.6% (95% CI, 1.4%-5.8%). The frequency of vertiginous episodes decreased, and the hearing level over the study period worsened from 40.9 dB to 44.5 dB, for a difference of 3.5 dB (95% CI, 0.7-6.4 dB). In this study, during a 2-year period of medical treatment among patients with Ménière disease, vestibuloocular reflex gain decreased in the vertical semicircular canals but was maintained in the horizontal semicircular canals; the endolymphatic hydrops volume ratio increased, and the frequency of vertiginous episodes decreased. These findings describe the pathological progression of chronic Ménière disease and expand the understanding of its pathophysiological characteristics during the early stage of disease.

Longitudinal Assessment of Symptoms and Risk of SARS-CoV-2 Infection in Healthcare Workers Across 5 Hospitals to Understand Ethnic Differences in Infection Risk

Objective: To understand ethnic differences in SARS-CoV-2 infection risk and symptoms in hospital healthcare workers (HCW).Methods: A Prospective longitudinal observational cohort study. 1364 HCW at five UK hospitals were studied with up to 16 weeks of symptom questionnaires and antibody testing (to both nucleocapsid and spike protein) during the first UK wave in five NHS hospitals. The main outcome measures were SARS-CoV-2 infection (seropositivity at any time-point) and symptoms.Results: 272 of 1364 HCW (mean age 40.7 years, 72% female, 74% white, ≥6 samples per participant) seroconverted, reporting predominantly mild or no symptoms. Seropositivity was lower in ITU workers (OR=0.43 95%CI 0.24, 0.76; p=0.0033). Seropositivity was higher in black (compared to white) participants, independent of age, sex, role and index of multiple deprivation (OR=2.61 95%CI 1.47-4.62 p=0.0009). No association was seen with other ethnic groups. Conclusions: In the UK first wave, black ethnicity (but not other ethnicities) more than doubled HCW infection risk, independent of age, sex, measured socio-economic factors and role.Trial Registration: NCT04318314Funding Statement: Funding for the PANTHER study was from the UKRI/MRC (Cov-0331 - MR/V027883/1 ), with additional institutional support from the Nottingham NIHR BRC. Funding for COVIDsortium was donated by individuals, charitable Trusts, and corporations including Goldman Sachs, Citadel and Citadel Securities, The Guy Foundation, GW Pharmaceuticals, Kusuma Trust, and Jagclif Charitable Trust, and enabled by Barts Charity with support from UCLH Charity. Wider support is acknowledged on the COVIDsortium website. Institutional support from Barts Health NHS Trust and Royal Free NHS Foundation Trust facilitated study processes, in partnership with University College London and Queen Mary University London. Serology tests (anti-S1 and anti-NP) were funded by Public Health England. JCM, CMa and TAT are directly and indirectly supported by the University College London Hospitals (UCLH) and Barts NIHR Biomedical Research Centres and through the British Heart Foundation (BHF) Accelerator Award (AA/18/6/34223). TAT is funded by a BHF Intermediate Research Fellowship (FS/19/35/34374). MN is supported by the Wellcome Trust (207511/Z/17/Z) and by NIHR Biomedical Research Funding to UCL and UCLH. None of the aforementioned funding bodies have contributed to the design, collection, or analysis of the data.Declaration of Interests: None to declare. Ethics Approval Statement: The study was approved by a UK Research Ethics Committee (South Central - Oxford A Research Ethics Committee, reference 20/SC/0149).

Increased mortality in elderly patients with acute respiratory distress syndrome is not explained by host response

BackgroundAdvanced age is associated with increased mortality in acute respiratory distress syndrome (ARDS) patients. Preclinical studies suggest that the host response to an injurious challenge is age-dependent. In ARDS patients, we investigated whether the association between age and mortality is mediated through age-related differences in the host response.MethodsThis was a prospective longitudinal observational cohort study, performed in the ICUs of two university-affiliated hospitals. The systemic host response was characterized in three predefined age-groups, based on the age-tertiles of the studied population: young (18 to 54 years, N = 209), middle-aged (55 to 67 years, N = 213), and elderly (67 years and older, N = 196). Biomarkers of inflammation, endothelial activation, and coagulation were determined in plasma obtained at the onset of ARDS. The primary outcome was 90-day mortality. A mediation analysis was performed to examine whether age-related differences in biomarker levels serve as potential causal pathways mediating the association between age and mortality.ResultsNinety-day mortality rates were 30% (63/209) in young, 37% (78/213) in middle-aged, and 43% (84/196) in elderly patients. Middle-aged and elderly patients had a higher risk of death compared to young patients (adjusted odds ratio, 1.5 [95% confidence interval 1.0 to 2.3] and 2.1 [1.4 to 3.4], respectively). Relative to young patients, the elderly had significantly lower systemic levels of biomarkers of inflammation and endothelial activation. Tissue plasminogen activator, a marker of coagulation, was the only biomarker that showed partial mediation (proportion of mediation, 10 [1 to 28] %).ConclusionLittle evidence was found that the association between age and mortality in ARDS patients is mediated through age-dependent differences in host response pathways. Only tissue plasminogen activator was identified as a possible mediator of interest.Trial registrationThis trial was registered at ClinicalTrials.gov (identifier NCT01905033, date of registration July 23, 2013).

Does a computerized neuropsychological test predict prolonged recovery in concussed children presenting to the ED?

ABSTRACTComputerized neuropsychological tests (CNTs) are widely used internationally in concussion management. Their prognostic value for predicting recovery post-concussion is poorly understood, particularly in pediatric populations. The aim of the present study was to examine whether cognitive functioning (measured by CogSport) has prognostic value for predicting rapid versus slow recovery. This is a prospective longitudinal observational cohort study conducted at a state-wide tertiary pediatric hospital. Data were collected at 1–4, 14, and 90 days post-injury. Eligible children were aged ≥5 and <18 years presenting to the Emergency Department having sustained a concussion within 48 h. Concussion was defined according to the Zurich/Berlin Consensus Statement on Concussion in Sport. Dependent variables were reaction times and error rates on the CogSport Brief Battery. In total, 220 cases were analyzed; 98 in a rapid recovery group (asymptomatic at 14 days post-injury, mean age 11.5 [3.2], 73.5% male) and 122 in a slow recovery group (symptomatic at 14 days post-injury, mean age 12.0 [3.1], 69.7% male). Longitudinal GEE analyses modeled the trajectories of both mean log10-transformed reaction time and error rates between groups over time (1–4, 14 and 90 days). Both group main and interaction (time by group) terms for all models were non-significant (p > .05). Cognitive functioning, measured by CogSport and assessed within 1–4 days of concussion, does not predict prolonged recovery in a pediatric sample. Further, there were no significant group differences at any time point. Considering the widespread use and promotion of CNTs, it is important that clinicians understand the significant limitations of the CogSport battery.

Nutrition-specific and nutrition-sensitive factors associated with mid-upper arm circumference as a measure of nutritional status in pregnant Ethiopian women: Implications for programming in the first 1000 days.

Poor nutritional status in pregnancy expressed as low mid-upper arm circumference (MUAC) is associated with low birth weight. The study aims were to assess the nutritional status of pregnant Ethiopian women using MUAC and examine association with nutrition-specific and nutrition-sensitive factors, using baseline data of a prospective longitudinal observational birth cohort study conducted in three rural districts in the Oromia region of Ethiopia. Recruitment into the cohort was rolling over a period of nine months, and the data used for this analysis were collected while the women were between 12–32 weeks of gestation. Detailed household socio-demographics, agricultural production, women’s health, morbidity and diets, with weights, heights and MUAC, and anemia prevalence (HemoCue) were collected. The prevalence of low MUAC (< 23 cm) was 41%. Controlling for location and clustering, wealth quintile (OR = 0.88, CI = 0.82 to 0.96, p<0.01) was associated with decreased risk of low MUAC, while trimester (OR = 1.31, CI = 1.16 to 1.48, p<0.001) was associated with increased risk of low MUAC. The only significant factor amenable to nutrition-specific interventions was altitude-adjusted anemia, which was associated with increased risk of low MUAC (OR = 1.28, CI = 1.09 to 1.49, p<0.01). Significant factors amenable to nutrition-sensitive factors and associated with higher odds of low MUAC were household food insecurity (OR = 1.04, CI = 1.02 to 1.06, p<0.001), distance to the clinic in minutes (OR = 1.01, CI = 1.0 to 1.01, p<0.0001) and season of recruitment (lean versus non lean) (OR = 1.30, CI = 1.10 to 1.54, p<0.01). Literacy (OR = 0.85, CI = 0.74 to 0.98, p<0.05) and numeracy (OR = 0.75, CI = 0.62 to 0.91, p<0.01) were also significantly associated with lower odds of low MUAC. Poor nutritional status in pregnancy expressed as percent with low MUAC was high in Ethiopian women. It was associated with several nutrition-specific and -sensitive factors indicating the importance of multisectoral actions in improving outcomes within the first 1000 days.

Risk Factors for Delayed Onset of Lactogenesis II Among Primiparous Mothers from a Brazilian Baby-Friendly Hospital.

Low milk supply is frequently reported as a reason for exclusive breastfeeding cessation. To determine the occurrence of, and the risk factors associated with, delayed onset of lactogenesis II among primiparas seen at a Baby-Friendly Hospital in Brazil. We conducted a prospective longitudinal observational cohort study of 224 primiparas who had a singleton delivery. Data were first collected at the hospital. We assessed the onset of lactogenesis on day four postpartum, based on maternal reports of changes in breast fullness. Breastfeeding practices and Edinburgh Postnatal Depression Scale were evaluated on day seven postpartum. Using Poisson regression, we assessed significant factors associated with delayed onset of lactogenesis II. Delayed lactogenesis II occurred in 18.8% (n = 42) of participants and was significantly associated with alcohol drinking during pregnancy (IRR = 2.710, 95% CI [1.469, 4.996]); Edinburgh Postnatal Depression Scale scores ≥ 10 (IRR = 2.092, 95% CI [1.118, 3.916]), and the age of the mother (IRR: 1.081, 95% CI [1.039, 1.125]). Postpartum depression and alcohol ingestion during pregnancy may be associated with lactogenesis II delay, but more research is needed to elucidate the directionality of these relationships. Older mothers are at risk of delayed lactogenesis II onset. The frequency of delayed lactogenesis in this population is similar to the rates seen in previous Latin America studies and much lower than the ranges seen in North America, possibly because of the low proportion of obesity and severe gestational diabetes in this sample.

Association of Continuous Assessment of Step Count by Remote Monitoring With Disability Progression Among Adults With Multiple Sclerosis

ImportanceDisability measures in multiple sclerosis (MS) fail to capture potentially important variability in walking behavior. More sensitive and ecologically valid outcome measures are needed to advance MS research.ObjectivesTo assess continuous step count activity remotely among individuals with MS for 1 year and determine how average daily step count is associated with other measures of MS disability.Design, Setting, and ParticipantsIn a prospective longitudinal observational cohort study, 95 adults with relapsing or progressive MS who were able to walk more than 2 minutes with or without an assistive device were recruited between June 15, 2015, and August 8, 2016, and remotely monitored in their natural environment for 1 year. Patients were excluded if they had a clinical relapse within 30 days or comorbidity contributing to ambulatory impairment. Longitudinal analysis was performed from October 2017 to March 2018. Revised analysis was performed in December 2018.InterventionActivity monitoring of step count using a wrist-worn accelerometer.Main Outcomes and MeasuresAverage daily step count compared with in-clinic assessments and patient-reported outcomes.ResultsOf the 95 participants recruited (59 women and 36 men; mean [SD] age, 49.6 [13.6] years [range, 22.0-74.0 years]), 35 (37%) had progressive MS, and the median baseline Expanded Disability Status Scale score was 4.0 (range, 0-6.5). At 1 year, 79 participants completed follow-up (83% retention). There was a modest reduction in accelerometer use during the 1 year of the study. A decreasing average daily step count during the study was associated with worsening of clinic-based outcomes (Timed 25-Foot Walk, β = −13.09; P < .001; Timed-Up-and-Go, β = −9.25; P < .001) and patient-reported outcomes (12-item Multiple Sclerosis Walking Scale, β = −17.96; P < .001). A decreasing average daily step count occurred even when the Expanded Disability Status Scale score remained stable, and 12 of 25 participants (48%) with a significant decrease in average daily step count during the study did not have a reduction on other standard clinic-based metrics. Participants with a baseline average daily step count below 4766 (cohort median) had higher odds of clinically meaningful disability (Expanded Disability Status Scale score) worsening at 1 year, adjusting for age, sex, and disease duration (odds ratio, 4.01; 95% CI, 1.17-13.78; P = .03).Conclusions and RelevanceContinuous remote activity monitoring of individuals with MS for 1 year appears to be feasible. In this study, a decreasing average daily step count during a 1-year period was associated with worsening of standard ambulatory measures but could also occur even when traditional disability measures remained stable. These results appear to support the prospect of using the average daily step count as a sensitive longitudinal outcome measure in MS and as a clinically relevant metric for targeted intervention.

Bleeding, cramping, and satisfaction among new copper IUD users: A prospective study

ObjectiveWe assess change in bleeding, cramping, and IUD satisfaction among new copper (Cu) IUD users during the first six months of use, and evaluate the impact of bleeding and cramping on method satisfaction.MethodsWe recruited 77 women ages 18–45 for this prospective longitudinal observational cohort study. Eligible women reported regular menses, had no exposure to hormonal contraception in the last three months, and desired a Cu IUD for contraception. We collected data prospectively for 180 days following IUD insertion. Monthly, participants reported bleeding scores using the validated pictorial blood loss assessment chart (PBAC), IUD satisfaction using a five-point Likert scale, and cramping using a six-level ordinal scale. We used multiple imputation to address nonrandom attrition. Structural equation models for count and ordered outcomes were used to model bleeding, cramping, and IUD satisfaction growth curves over the six monthly repeated assessments.ResultsBleeding significantly decreased (approximately 23%) over the course of the study from an estimated PBAC = 195 at one month post-insertion to PBAC = 151 at six months (t = -2.38, p<0.05). Additionally, IUD satisfaction improved over time (t = 2.65, p<0.01), increasing from between “Neutral” and “Satisfied” to “Satisfied” over the six month study. Cramping decreased notably over the six month study from between biweekly and weekly, to once or twice a month (t = -4.38, p<0.001). Finally, bleeding, but not cramping, was associated with IUD satisfaction across the study (t = -2.31, p<0.05) and at study end (t = -2.81, p<0.01).ConclusionsNew Cu IUD users reported decreasing bleeding and cramping, and increasing IUD satisfaction, over the first six months. Method satisfaction was negatively associated with bleeding.

Protocol and rationale for the first South Asian 5-year prospective longitudinal observational cohort study and biomarker evaluation investigating the clinical course and risk profile of IgA nephropathy: GRACE IgANI cohort

Background: IgA nephropathy (IgAN) is the most common primary glomerulonephritis and an important cause of end-stage kidney disease. Unlike the slowly progressive course seen among Caucasian and East Asian subjects (actuarial survival 80-85% over 10 years), in India about 30-40% of patients have nephrotic syndrome and renal dysfunction at presentation and a 10-year renal survival of 35%, as reported from a retrospective registry. These observations cannot be entirely attributed to a lack of uniform screening protocols or late referral and attest to the probability that IgAN may not be the same disease in different parts of the world. Methods: We will prospectively recruit 200 patients with IgAN (the GRACE IgANI— Glomerular Research And Clinical Experiments- Ig A Nephropathy in Indians—cohort) and stratify them into low and high risk of progression based on published absolute renal risk scores. We will test the validity of this risk score in an unselected Indian IgAN population over a 5-year follow-up period. In parallel, we will undertake extensive exploratory serum, urine, renal and microbiome biomarker studies, firstly, to determine if the underlying pathogenic pathways are the same in Indian IgAN compared to those reported in Caucasian and East Asian IgAN. Secondly, we will systematically assess the value of measuring selected biomarkers and adding this data to traditional measures of risk in IgAN to predict kidney failure. We ultimately hope to generate a composite IgAN risk score specific for the Indian population. Ethics and data dissemination: Approval was obtained from the Institutional Review Board (Silver, Research and Ethics Committee) of the Christian Medical College, Vellore, India (Ref. No. IRB Min. No. 8962 [Other] dated 23.07.2014 and IRB Min. No. 9481 [Other] dated 24.06.2015). It is anticipated that results of this study will be presented at national and international meetings, with reports being published from late 2018.

Protocol and rationale for the first South Asian 5-year prospective longitudinal observational cohort study and biomarker evaluation investigating the clinical course and risk profile of IgA nephropathy: GRACE IgANI cohort.

Background: IgA nephropathy (IgAN) is the most common primary glomerulonephritis and an important cause of end-stage kidney disease. Unlike the slowly progressive course seen among Caucasian and East Asian subjects (actuarial survival 80-85% over 10 years), in India about 30-40% of patients have nephrotic syndrome and renal dysfunction at presentation and a 10-year renal survival of 35%, as reported from a retrospective registry. These observations cannot be entirely attributed to a lack of uniform screening protocols or late referral and attest to the probability that IgAN may not be the same disease in different parts of the world. Methods: We will prospectively recruit 200 patients with IgAN (the GRACE IgANI- Glomerular Research And Clinical Experiments- Ig A Nephropathy in Indians-cohort) and stratify them into low and high risk of progression based on published absolute renal risk scores. We will test the validity of this risk score in an unselected Indian IgAN population over a 5-year follow-up period. In parallel, we will undertake extensive exploratory serum, urine, renal and microbiome biomarker studies, firstly, to determine if the underlying pathogenic pathways are the same in Indian IgAN compared to those reported in Caucasian and East Asian IgAN. Secondly, we will systematically assess the value of measuring selected biomarkers and adding this data to traditional measures of risk in IgAN to predict kidney failure. We ultimately hope to generate a composite IgAN risk score specific for the Indian population. Ethics and data dissemination: Approval was obtained from the Institutional Review Board (Silver, Research and Ethics Committee) of the Christian Medical College, Vellore, India (Ref. No. IRB Min. No. 8962 [Other] dated 23.07.2014 and IRB Min. No. 9481 [Other] dated 24.06.2015). It is anticipated that results of this study will be presented at national and international meetings, with reports being published from late 2018.

The Pediatric Stroke Outcome Measure: A predictor of outcome following arterial ischemic stroke.

To evaluate the relationship between neurologic outcome at 1 month following diagnosis of pediatric arterial ischemic stroke (AIS) and motor and adaptive behavior outcomes at 12 months. This prospective longitudinal observational cohort study recruited children from a single tertiary children's hospital diagnosed with first AIS between December 2007 and November 2013. Neurologic impairment was evaluated at 4 time points using the Pediatric Stroke Outcome Measure (PSOM) or Recovery and Recurrence Questionnaire following diagnosis of AIS (acute, 1, 6, and 12 months). Motor function and adaptive behavior were assessed at 12 months using standardized measures. Children were grouped for analysis, according to age at diagnosis (neonates vs preschool vs school-aged). The relationship between neurologic impairment and 12-month functional outcomes were examined. Sixty-four children were recruited (27 neonates, 19 preschool-aged, and 18 school-aged). Presence of impairment on the PSOM at 1 month was associated with lower 12-month fine motor z scores (p = 0.004), gross motor z scores (p = 0.001), and adaptive behavior standard scores (p = 0.004). One-month PSOM impairment score was more predictive than age group or lesion size of 12-month motor and adaptive behavior outcome. The PSOM has value as a predictive tool when used at 1 month after first AIS diagnosed acutely in relation to motor and adaptive behavior, with variation according to age group.

Spotlight on the January 30 issue

#### Notable in Neurology ® this week This issue features an article that illustrates the importance of funduscopic examination in the emergency department for optic nerve head edema in patients presenting with headache, neurologic deficit, visual loss, or elevated blood pressure; and another that reports the accurate detection of generalized tonic-clonic seizures by a wearable surface EMG device. A featured Views & Reviews article accounts the barriers to overcoming the dementia challenge in Latin American countries. ### The Pediatric Stroke Outcome Measure: A predictor of outcome following arterial ischemic stroke In this prospective longitudinal observational cohort study, neurologic impairment in …

Consulta de enfermería y adherencia terapéutica del paciente en hemodiálisis

de hemodiálisis se producen muchas interferencias en la comunicación ya que simultáneamente atendemos a otros pacientes y se presentan complicaciones que tendremos que resolver de forma inmediata. Mediante la consulta de enfermería se pretende evitar esto, y darle el valor y tiempo que tienen las intervenciones enfermeras que son parte del tratamiento. Debemos asegurar que el paciente recibe instrucciones terapéuticas correctamente escritas, revisarlas y verificarlas con él para poder hacer un ajuste de niveles de comprensión, además de motivarlo y corresponsabilizarlo para lograr la adquisición de conductas implicadas en su autocuidado. Objetivo: Evaluar el efecto de la consulta de enfermería al paciente renal en hemodiálisis sobre el cumplimiento terapéutico. Material y Método: Estudio observacional longitudinal prospectivo de cohorte. Muestra de 42 pacientes en programa de hemodiálisis desde enero a junio 2014. Los pacientes seleccionados para la consulta son aquellos para los que la investigadora del estudio es enfermera referente y colaboradora (Grupo A). Se recogen datos de las diferentes variables revisando las historias clínicas y mediante la entrevista con el paciente y cuidador principal. Resultados: Encontramos diferencias significativas al comparar las variables estudiadas entre el Grupo A y Grupo B (resto pacientes) en cuanto al fósforo y cumplimiento farmacológico, pero no se encontraron en cuanto al potasio aunque la tendencia es a mejorar los niveles. Conclusiones: La consulta de enfermería mejora la adherencia terapéutica en dieta y medicación, relacionándose con un mayor tiempo de dedicación al tratamiento y mayor contacto con el cuidador principal.

Persistent Pain After Caesarean Section and Its Association With Maternal Anxiety and Socioeconomic Background

(Abstracted from Int J Obstet Anesth, 29:57–63, 2017) The purpose of this prospective longitudinal observational cohort study was to define the incidence of new persistent pain after elective cesarean delivery in a largely socially deprived, urban Scottish population. The authors also aimed to correlate antenatal anxiety with persistent pain.

Incidence, risk factors and the healthcare cost of falls postdischarge after elective total hip and total knee replacement surgery: protocol for a prospective observational cohort study.

IntroductionThe number of major joint replacement procedures continues to increase in Australia. The primary aim of this study is to determine the incidence of falls in the first 12 months after discharge from hospital in a cohort of older patients who undergo elective total hip or total knee replacement.Methods and analysesA prospective longitudinal observational cohort study starting in July 2015, enrolling patients aged ≥60 years who are admitted for elective major joint replacement (n=267 total hip replacement, n=267 total knee replacement) and are to be discharged to the community. Participants are followed up for 12 months after hospital discharge. The primary outcome measure is the rate of falls per thousand patient-days. Falls data will be collected by 2 methods: issuing a falls diary to each participant and telephoning participants monthly after discharge. Secondary outcomes include the rate of injurious falls and health-related quality of life. Patient-rated outcomes will be measured using the Oxford Hip or Oxford Knee score. Generalised linear mixed modelling will be used to examine the falls outcomes in the 12 months after discharge and to examine patient and clinical characteristics predictive of falls. An economic evaluation will be conducted to describe the nature of healthcare costs in the first 12 months after elective joint replacement and estimate costs directly attributable to fall events.Ethics and disseminationThe results will be disseminated through local site networks and will inform future services to support older people undergoing hip or knee joint replacement and also through peer-reviewed publications and medical conferences. This study has been approved by The University of Notre Dame Australia and local hospital human research ethics committees.Trial registration numberACTRN12615000653561; Pre-results.

Etanercept Increases Bone Mineral Density in Ankylosing Spondylitis, but Does Not Prevent Vertebral Fractures: Results of a Prospective Observational Cohort Study

Ankylosing spondylitis (AS) is characterized by chronic inflammation leading to ankylosis, but also to low bone mineral density (BMD) and vertebral fractures (VFx). Treatment with tumor necrosis factor-α blockers decreases inflammation and has shown to be effective in increasing BMD. We studied the effects of etanercept (ETN) on BMD and VFx in patients with AS after 2 years of treatment. Further, we studied changes in bone turnover markers and radiological damage. Patients with active AS, treated with ETN for 2 years, were included. BMD lumbar spine and hip were measured at baseline and after 2 years, as well as radiological damage (modified Stoke Ankylosing Spondylitis Spinal Score with the addition of the thoracic spine), VFx (Genant method), and change in bone turnover markers. Forty-nine patients with AS were included. After 2 years of ETN, hip BMD increased by 2.2% (p = 0.014) and lumbar spine BMD by 7.0% (p < 0.001). The Bath Ankylosing Spondylitis Disease Activity Index decreased significantly (p < 0.001), as well as C-reactive protein and erythrocyte sedimentation rate (p < 0.001). Despite ETN therapy, the number of patients with VFx more than doubled (from 6 to 15 patients, p = 0.003). Also, the radiological damage increased significantly over time (from 12.1 to 18.5, p < 0.001); however, no significant change in bone turnover markers was found. This prospective longitudinal observational cohort study showed that after 2 years of ETN, BMD of the hip and spine increased significantly, but the number of patients with VFx and the severity of VFx increased as well. Besides that, radiological progression, including the thoracic spine, increased significantly. Thus, the favorable bone-preserving effect is accompanied by unfavorable outcomes on VFx and radiological damage.

Spinal radiographic progression in patients with ankylosing spondylitis treated with TNF-α blocking therapy: a prospective longitudinal observational cohort study.

ObjectivesTo evaluate spinal radiographic damage over time and to explore the associations of radiographic progression with patient characteristics and clinical assessments including disease activity in ankylosing spondylitis (AS) patients treated with tumor necrosis factor-alpha (TNF-α) blocking therapy in daily clinical practice.MethodsConsecutive outpatients from the Groningen Leeuwarden AS (GLAS) cohort were included based on the availability of cervical and lumbar radiographs before start of TNF-α blocking therapy and after 2, 4, and/or 6 years of follow-up. Clinical data were assessed at the same time points. Radiographs were scored by two independent readers using the modified Stoke AS Spine Score (mSASSS). Spinal radiographic progression in relation to clinical assessments was analyzed using generalized estimating equations.Results176 AS patients were included, 58% had syndesmophytes at baseline. Median mSASSS increased significantly from 10.7 (IQR: 4.6–24.0) at baseline to 14.8 (IQR: 7.9–32.8) at 6 years. At the group level, spinal radiographic progression was linear with a mean progression rate of 1.3 mSASSS units per 2 years. Both spinal radiographic damage at baseline and radiographic progression were highly variable between AS patients. Male gender, older age, longer disease duration, higher BMI, longer smoking duration, high CRP, and high ASDAS were significantly associated with syndesmophytes at baseline. Significantly more radiographic progression was seen in patients with versus without syndesmophytes (2.0 vs. 0.5 mSASSS units per 2 years) and in patients >40 versus ≤40 years of age (1.8 vs. 0.7 mSASSS units per 2 years). No longitudinal associations between radiographic progression and clinical assessments were found.ConclusionsThis prospective longitudinal observational cohort study in daily clinical practice shows overall slow and linear spinal radiographic progression in AS patients treated with TNF-α blocking therapy. At the individual level, progression was highly variable. Patients with syndesmophytes at baseline showed a 4-fold higher radiographic progression rate than patients without syndesmophytes.